Will DEA Regulations Hinder EMS Use of Controlled Substances?

Scenario:EMS is called to a pediatric seizure. On arrival, the 2-year-old child, who has a known seizure disorder, is still seizing. Paramedic’s start an IV and check a glucose (98). The child persists in seizing and is becoming cyanotic. Paramedics draw up 2mg of midazolam and contact online medical control (OLMC) for permission to give midazolam…

In this scenario, EMS practitioners who are well trained with reasonable EMS protocols and involved EMS physician oversight in place were able to act without delay to potentially save a life and alleviate pain and suffering. Delays in care caused by taking the time to contact online medical control or worse, an inability to reach OLMC, could have serious repercussions on emergency patients. Yet, this is what could happen if the DEA were to act upon a new set of EMS-specific regulations that would include prohibitions against standing orders for controlled substances. It was this threat that caused the advocacy arms of the National Association of EMS Physicians (NAEMSP) and ACEP – along with the National Association of EMTs (NAEMT) and other EMS partners – to move forward to craft the Protecting Patient’s Access to Emergency Medications Act of 2016.

Before we discuss the current legislation, let’s take a look at some history. The Controlled Substances Act (CSA) is the legislation that gives the Drug Enforcement Agency authority to regulate controlled substances. It was written in 1970. As a point of reference, the TV show Emergency!, which was the first media portrayal of the “advanced” care provided by paramedics, first hit the airwaves in 1972. The CSA is based on “brick and mortar” situations such as hospitals, pharmacies and clinics and made no mention of EMS. The Act has been updated legislatively many times but still does not include EMS specific language. The DEA is not a medical agency: it is law enforcement and has legislative authority to regulate controlled substances as defined by CSA. When seen through a strictly law enforcement lens, the current nationwide EMS standard does not conform with the written standard and therefore presents a potential enforcement issue.

The lack of EMS-specific regulation has led to wide variation in enforcement and practice. In most states, the EMS Medical Director obtains the DEA registration for their agency. As a result, the individual medical director may be personally liable for any controlled substances issues. This issue was made all too clear in 2009 when the DEA sought to fine a volunteer EMS Medical Director in Texas between and $2 million and $7 million when he discovered significant diversion in his agency and then reported it to the DEA. Additionally, DEA expectations for EMS agencies vary widely. Many locations require medical director to obtain a DEA registration for each physical station or location that houses a response unit. As a result, there are medical directors with greater than 50 separate DEA registrations. In some settings, the DEA expects the EMS agency to be registered as a “Distributor” because they distribute medications throughout the system. In other states, ambulance agencies can register as a “mid-level” provider – similar to a physician assistant or a nurse practitioner.

It was in this environment that the DEA announced that they would be creating a set of EMS specific regulations. This was, in fact, met with a positive response in the EMS community. There would finally be one set of rules under which all of EMS would operate. The DEA even reached out to the community. In the fall of 2014, members of the DEA who were tasked with writing these regulations met with the ACEP EMS Committee at the ACEP meeting. This was followed up with a meeting with NAEMSP Executive Committee in January 2015 – at the NAEMSP Annual Meeting in New Orleans. The DEA staff wanted to learn how EMS operates and how to focus on diversion prevention. They even floated the idea of creating an agency registration instead of relying on the EMS Medical Director. It all sounded reasonable until they dropped the bombshell. They stated that the Controlled Substances Act only allowed for patient-specific orders for controlled substances and that it was not legal for EMS agencies to deliver any controlled substances under protocols or “standing orders.” In further discussion, it was their position that the language of the statute did not give them any leeway for interpretation and that the regulations would very specifically state that protocol-driven usage of controlled substances is not allowed. At this point, the only solution would be a legislative fix – introducing a bill that would formally amend the CSA.

This brings us to the Protecting Patient Access to Emergency Medications Act of 2016.

The Legislative Fix
This bill was first introduced as HR 4365. Representative Richard Hudson (R-NC-8) introduced the bill in January of 2016. The bill was immediately bipartisan, with support from Representative Butterfield (D-NC-1). ACEP members Representative Dr. Joseph Heck (R-NV-3) and Representative Dr. Raul Ruiz (D-CA-36) were also original cosponsors and key supporters. Dr. Heck is also a former NAEMSP member. Approximately 5 months later, Senator Dr. Bill Cassidy (R-LA) introduced the Senate version – S.2932.

What are the key components of these bills? Although there are some differences in structure and language, the overall result is the same and boils down to three things:

EMS practitioners will be able to give patients a controlled substance based on standing orders.

The EMS agency will be the registrant to the DEA, instead of the individual medical director.

The DEA may only require one DEA registration per state for EMS agency (although more would be allowed)

Additionally, an EMS agency is required to have a physician Medical Director, which would be the first acknowledgment of EMS medical direction in Federal statute.

The bill has received unprecedented support within the EMS community, with endorsements from organizations ranging from the National Association of EMS Physicians to the American College of Emergency Physicians and the International Association of Fire Fighters.

The House version of the bill had a hearing before the House Energy and Commerce Committee (Subcommittee on Health) in July, 2016. Dr. Brent Myers (President-elect NAEMSP) and Dr. Craig Manifold (Chairman of the ACEP EMS Committee) testified before the Committee in support of the bill. The bill was passed through committee in September and now awaits passage on the floor of the House of Representatives. Unfortunately, both chambers of Congress are now recessed until after the election and it will be dependent on the “lame duck” portion of the session to move the bill to passage. Passage of the bill is not the end of the line, however. The DEA will still need to promulgate EMS specific regulations and it will be important that the organizations involved in EMS maintain vigilance and involve themselves in the regulatory process.

The bill has been heavily lobbied by the above organizations, along with significant grass roots level support and interaction. The bill was an ask at both the NAEMT-organized “EMS on the Hill” day and ACEP’s Leadership and Advocacy Conference. During congressional visits, lobbyists heard that the grassroots support was making a difference. Most bills get referred to committee and meet their death before even reaching a hearing. Many bills that are ultimately enacted required multiple introductions over many years before enactment. The fact that a bill introduced in January may reach enactment this year is a testament to the importance of the bill, the effectiveness of the grassroots message as well as the power unanimity of the EMS community. While the task remains difficult, optimism persists that the bill will pass.

Lessons learned? Disabuse yourself of the notion that a well-reasoned outcry by physician leaders across the country in reaction to a detrimental change to patient care can itself change the path chosen by a mission-focused arm of government. The only way to effect change in this arena is through effective lobbying and engagement with the rule makers in Washington. That takes physician commitment and, frankly, funding for professional lobbying.

1 Comment

Hopefully the efforts of NAEMSP and others will get the DEA to understand the benefits of protocol supported and well monitored EMS use of controlled substances. I must caution that it is also absolutely necessary that careful review of their utilization is needed by our own EM/EMS oversight especially in today’s increased attention to opioid misuse. I have noted a disturbing trend in EMS where patients are administered narcotics, especially fentanyl, in the prehospital setting for frankly minor pain conditions or patients with chronic pain syndromes. The very patients we are seeking alternatives to narcotic management in the ED for their chronic (say) back pain are getting treated with narcotics before they even get to the hospital. We created a huge problem with patient expectations coming into the ED for opioid management, let’s not create an expectation that the ride in will be the same. If we don’t, over zealous regulations by others will limit our capability to treat those with clearly severe acute pain.

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